a study to evaluate the efficacy and safety of cyclo-z in patients with obese type 2 diabetes

Conditions: Diabetes Mellitus Type 2 in Obese

Summary: this is a double-blind, randomized, placebo-controlled, parallel-group comparison study to evaluate the efficacy and safety of cyclo-z for the treatment of subjects with obese type 2 diabetes. the study will consist of 3 phases: * screening phase (2 weeks) * treatment phase (12 weeks) * follow-up phase (2 weeks) following a 2-week screening period, subjects who meet all inclusion and exclusion criteria will be randomly assigned into one of the following treatment arms: * dose a: cyclo-z containing 23 mg zinc plus 3 mg chp - 16 subjects * dose b: cyclo-z containing 23 mg zinc plus 9 mg chp - 16 subjects * dose c: cyclo-z containing 23 mg zinc plus 15 mg chp - 16 subjects * dose d: placebo - 16 subjects the assigned dose will be orally administered to subjects once a day before bedtime for 12 consecutive weeks. after the randomization at week 0 (visit 2), subjects will visit their respective trial sites at weeks 2, 4, 6, 8, 10, 12, and 14 (visits 3, 4, 5, 6, 7, 8, and 9).


Eligibility criteria:
inclusion criteria: 1. males or females aged 18 or older. 2. subjects diagnosed with type 2 diabetes mellitus according to the american diabetes association (ada) criteria. 3. subjects treated with stable doses of insulin and/or other hypoglycemic agent(s) for type 2 diabetes mellitus for at least 2 months prior to randomization. 4. subjects whose fasting blood glucose levels are reasonably stable for at least 2 months prior to randomization and during the 2-week screening period. 5. subjects who have hemoglobin a1c levels of 7.5 to 10.0 % at screening. 6. subjects whose bmi is 30 or above. 7. subjects who can give written informed consent. exclusion criteria: 1. subjects who have any dm-related end-organ damages. 2. subjects who have a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma. 3. subjects who have any disease likely to limit life span and/or increase risks of interventions such as: * carotid b-mode ultrasound test results indicating clinically significant stenosis in the common carotid arteries requiring intervention by angioplasty or resection. * cancer treatment in the past 5 years, with the exception of cancers which have been cured, and carry a good prognosis. * infectious disease: hiv positivity, active tuberculosis, or pneumonia. 4. subjects who have any of the following conditions related to cardiovascular disease: * hospitalization for the treatment of heart disease in the past 12 months. * new york heart association functional class \> 2. * left bundle branch block on ecg at screening. * third degree atrioventricular block on ecg at screening. * uncontrolled hypertension with average systolic blood pressure of \> 160 mmhg or diastolic blood pressure \> 95 mmhg at screening and baseline. * pulse rate \> 95 beats per minute at screening and baseline. * stroke or transient ischemic attack in the past 12 months. 5. subjects who have any of the following conditions related to gastrointestinal disease: * chronic hepatitis or cirrhosis. * episode of alcoholic hepatitis or alcoholic pancreatitis in the past 2 months. * inflammatory bowel disease requiring treatment in the past 12 months. * significant abdominal surgery (e.g., gastrectomy, gastric bypass) in the past 2 months. 6. subjects who have serum creatinine \> 1.5 mg/dl for male or \> 1.4 mg/dl for female. 7. subjects who have chronic obstructive airway disease or asthma requiring daily therapy or home use oxygen. 8. subjects who have hematocrit \< 36.0% for male or \< 33.0% for female. 9. subjects who have any of the following conditions or behaviors likely to affect the conduct of the study: * weight loss of \> 10% in the past 6 months. * unable to walk without assisted device. * major psychiatric disorder which would impede conduct of the research. * excessive alcohol intake (i.e., more than 2 drinks/day). 10. subjects who take any of the following medications: * psychoactive agents such as monoamine oxidase inhibitors and antidepressants (e.g., lithium, prozac, zoloft, serzone, paxil, effexor). * any other medications that may pose harm to the subject. 11. female subjects who have a positive serum pregnancy test at screening, plan a pregnancy during study period, or are breast feeding. 12. female subjects who don't meet any of the following criteria: * surgically sterile (i.e., have had bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 months before randomization. * post-menopausal for at least 12 months prior to screening. * if sexually active, they should use oral contraceptives, double barrier contraception (e.g., condom with spermicide), intrauterine device, or other methods approved by the sponsor.